Status:
COMPLETED
Dapagliflozin After Transcatheter Aortic Valve Implantation
Lead Sponsor:
Spanish Society of Cardiology
Collaborating Sponsors:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Conditions:
Aortic Stenosis
Transcatether Aortic Valve Implantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe...
Detailed Description
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) betwee...
Eligibility Criteria
Inclusion
- SEVERE AORTIC STENOSIS UNDERWENT TAVI
- PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:
- Left ventricular ejection fraction ≤ 40% or
- Diabetes mellitus or
- Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2
Exclusion
- Known allergy or intolerance to SGLT2 inhibitors.
- Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
- Systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg.
- An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
- Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
- Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
- Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
- Pregnant or breast-feeding patients
- Patients participating in other clinical trials.
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
1257 Patients enrolled
Trial Details
Trial ID
NCT04696185
Start Date
January 27 2021
End Date
December 30 2024
Last Update
January 10 2025
Active Locations (40)
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1
Hospital Juan Canalejo
A Coruña, Spain
2
Hospital Universitario de Albacete
Albacete, Spain
3
Hospital General Universitario de Alicante
Alicante, Spain
4
Hospital Universitario de Cruces
Barakaldo, Spain